SEROQUEL TABLET 200 mg

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

QUETIAPINE FUMARATE EQV QUETIAPINE

Dostępny od:

LUYE PHARMA (SINGAPORE) PTE. LTD.

Kod ATC:

N05AH04

Dawkowanie:

200 mg

Forma farmaceutyczna:

TABLET, FILM COATED

Skład:

QUETIAPINE FUMARATE EQV QUETIAPINE 200 mg

Droga podania:

ORAL

Typ recepty:

Prescription Only

Wyprodukowano przez:

ASTRAZENECA UK LTD

Status autoryzacji:

ACTIVE

Data autoryzacji:

1998-05-16

Ulotka dla pacjenta

Page 1 of 22 

PROPOSED PACKAGE INSERT – NON-ANNOTATED  

10/AA/SG/CNS.000-072-297.11.0 

PACKAGE LEAFLET TEXT 

SEROQUEL
TM

_QUETIAPINE FUMARATE _
TRADEMARK

PRESENTATION 
_25 mg tablet:_ round, 6 mm, peach coloured, biconvex, film-coated
tablet containing 
quetiapine fumarate delivering a dose of 25 mg of quetiapine
free base. 
_100 mg tablet:_  round,_ _8.5 mm, yellow coloured, biconvex,
film-coated tablet containing 
quetiapine fumarate delivering a dose of 100 mg of quetiapine
free base. 
_200 mg tablet:_ round, 11 mm, white, biconvex, film-coated
tablet containing quetiapine 
fumarate delivering a dose of 200 mg of quetiapine free base. 
_300 mg tablet: _capsule shaped, 19 mm x 7.62 mm, white,
film-coated tablet containing 
quetiapine fumarate delivering a dose of 300 mg of quetiapine
free base. 
For excipients see ‘Pharmaceutical Particulars’. 

INDICATIONS_ _
SEROQUEL is indicated for the treatment of: 
  schizophrenia. 
  acute manic episodes associated with bipolar I disorder. 
  depressive episodes associated with bipolar disorder. 
  preventing recurrence in maintenance treatment
of bipolar I disorder (manic, mixed or 
depressive episode) as monotherapy or in combination with lithium or
valproate. 

POSOLOGY AND METHOD OF ADMINISTRATION 
_ADULTS _
_FOR THE TREATMENT OF SCHIZOPHRENIA: _
SEROQUEL should be administered twice daily, with or
without food. 
For the treatment of schizophrenia:  the total daily dose for the
first 4 days of therapy is 50 
mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300
mg (Day 4). 

Page 2 of 22 
From Day 4 onwards, the dose should be titrated to the usual
effective dose range of 300 to 
450 mg/day.  Depending on the clinical response and
tolerability of the individual patient, 
the dose may be adjusted within the range 150 to 750 mg/day. 
_ _
_FOR THE

Charakterystyka produktu

Page 1 of 22
SEROQUEL
®
_QUETIAPINE FUMARATE _
PRESENTATION
_25 mg tablet:_ round, 6 mm, peach coloured, biconvex, film-coated
tablet containing quetiapine
fumarate delivering a dose of 25 mg of quetiapine free base.
_100 mg tablet:_ round,_ _8.5 mm, yellow coloured, biconvex,
film-coated tablet containing
quetiapine fumarate delivering a dose of 100 mg of quetiapine free
base.
_200 mg tablet:_ round, 11 mm, white, biconvex, film-coated tablet
containing quetiapine fumarate
delivering a dose of 200 mg of quetiapine free base.
_300 mg tablet: _capsule shaped, 19 mm x 7.62 mm, white, film-coated
tablet containing
quetiapine fumarate delivering a dose of 300 mg of quetiapine free
base.
For excipients see ‘Pharmaceutical Particulars’.
INDICATIONS_ _
SEROQUEL is indicated for the treatment of:

schizophrenia.

acute manic episodes associated with bipolar I disorder.

depressive episodes associated with bipolar disorder.

preventing recurrence in maintenance treatment of bipolar I disorder
(manic, mixed or
depressive episode) as monotherapy or in combination with lithium or
valproate.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
FOR THE TREATMENT OF SCHIZOPHRENIA:
SEROQUEL should be administered twice daily, with or without food.
For the treatment of schizophrenia: the total daily dose for the first
4 days of therapy is 50 mg
(Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4).
From Day 4 onwards, the dose should be titrated to the usual effective
dose range of 300 to
450 mg/day. Depending on the clinical response and tolerability of the
individual patient, the
dose may be adjusted within the range 150 to 750 mg/day.
_ _
FOR THE TREATMENT OF MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER:
SEROQUEL should be administered twice daily, with or without food._ _
As monotherapy or as adjunct therapy to mood stabilizers, the total
daily dose for the first four
days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and
400 mg (Day 4).
Further dosage adjustments up to 800 mg per day by Day 6